BBLCRYSTAL GRAM-POSITIVE ID SYSTEM
FDA 510(k) clearance K961968 · decided 1997-02-04
Clearance details
- K-number
- K961968
- Device name
- BBLCRYSTAL GRAM-POSITIVE ID SYSTEM
- Applicant
- Bd Becton Dickinson Vacutainer Systems Preanalytic
- Decision
- Substantially Equivalent
- Date received
- 1996-05-20
- Decision date
- 1997-02-04
- Days to decision
- 260 days
- Clearance type
- Traditional
- Product code
- LQL
- Device class
- 1
- Regulation number
- 866.2660
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Cockeysville, MD, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| GRAM POSITIVE AUTOIDENTIFICATION PLATES, SENSITITRE AP90 (K972576) | Accumed Intl., Inc. | 1998-01-22 |
| RAPID GRAM-POSITIVE ID SYSTEM (K961730) | Becton Dickinson Microbiology Systems | 1997-02-04 |
| VITEK GRAM POSITIVE IDENTIFICATION CARD (GPI) (K952095) | Biomerieux Vitek, Inc. | 1996-03-12 |
| VITEK RAPID CALL-GRAM POSITIVE IDENTIFICATION CARD (K925916) | Biomerieux Vitek, Inc. | 1993-03-23 |
| RAPID CORYNE SYST/IDENTIF OF CORYNEFORM BACTERIA (K910304) | Vitek Systems, Inc. | 1991-07-26 |
| VISI-STREP (K910537) | Kev Connecticut Diagnostics, Inc. | 1991-04-12 |
| MODIFICATION TO API UNISCEPT 20GP (K901559) | Analytical Products, Inc. | 1990-09-10 |
| RAPIDEC STAPH (K891004) | Dms Products, Inc. | 1989-11-09 |
| CATHRA GRAM POSITIVE SCREEN (K874606) | Mct Medical, Inc. | 1988-05-06 |
| GRAM POSITIVE FLUORESCENT IDENTIFICATION PANEL (K863038) | American Micro Scan | 1986-09-30 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| OXYCELL (N5798/S007) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1995-07-24 |
| OXYCEL OXIDIZED (N5798/S005) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1991-02-08 |
| OXYCELL (N5798/S006) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1991-02-08 |
| MINI BALLOON (P780011/S012) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1989-10-30 |
| MINI BALLOON (P780011/S011) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1988-10-18 |
| MINI BALLOON (P780011/S010) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1988-01-29 |
| MINI BALLOON (P780011/S007) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1985-01-23 |
| BBL SCEPTOR SYSTEM MICRODILUTION ANTIMICROBIC SUSC (P800030/S006) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1984-11-05 |